To evaluate the efficacy and safety of Asthiposhak Vati in patients suffering from Asthikshaya

Phase 4

Completed

• Conditions: Health Condition 1: - Health Condition 2: M859- Disorder of bone density and structure, unspecifiedHealth Condition 3: M859- Disorder of bone density and structure, unspecified

• Registration Number: CTRI/2019/09/021315
• Lead Sponsor: Shri Dhootapapeshwar Limited Mumbai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1.Patients of either sex between the age group of 40-75 years (both years inclusive)

2.Patients suffering from ASTHIKSHAYA (Osteopenia) with BMD T- score between (-1 to -2.5)

3.Those with a history of fractures that may have occurred with a minor injury or fall

4.Ready to abide by trial procedures and to give informed consent

Exclusion Criteria

1.Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphosphonates, calcitonin, Vit.D (more than 60,000 units) and corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months, methotrexate, anti- convulsants, diuretics, etc.

2.Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)

3.Patient suffering from Osteomalacia, Tumor, Osteonecrosis, Infection, and other bone-softening metabolic disorders.

4.Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome)

5.Patients with Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfect or Renal osteodystrophy, Malabsorption syndrome

6.Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome)

7.Patients who have undergone Organ transplantation

8.Patients who are immobilized since > 6 weeks

9.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

10.Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)

11.Any other serious illness e.g. Hepatic/renal failure.

12.Patient receiving any other method of treatment.

13.Patients requiring long term treatment of oral and/or injectable steroids or surgical intervention.

14.Symptomatic patient with clinical evidence of Heart failure.

15.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

16.Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)

17.Alcoholics and/or drug abusers.

18.Pregnant and lactating women,

19.H/o hypersensitivity to any of the trial drugs or their ingredients

20.Patients who have completed participation in any other clinical trial during the past six (06) months.

21.Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a)To assess the change in the BMD score after intervention.Timepoint: a)To assess the change in the BMD score after intervention at 8th visit (180 dqys)

Secondary Outcome Measures

Name	Time	Method
To evaluate the change in the Ayurvedic symptom after intervention.Timepoint: To evaluate the change in the Ayurvedic symptom score after intervention at 8th visit (180 days)